FDA.reportPublic FDA data

Dermal Cooling System

Primary DI
00850019947991
Brand
Dermal Cooling System
Company
R2 DERMATOLOGY INC.
Model
M1-TIP1-20
Catalog number
M1-TIP1-20
Device description
Dermal Cooling System smooth tip
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, hot or cold, water circulating
QPZContact cooling for skin lesion pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
QPZContact Cooling For Skin Lesion Pain ReliefGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213294000Dermal Cooling SystemR2 Technologies, Inc.2022-11-10QPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019947564PrimaryGS10
00850019947861PrimaryGS10
00850019947991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019947564008500199475648500199475640850019947564
00850019947861008500199478618500199478610850019947861
00850019947991008500199479918500199479910850019947991

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, thermo-electric coolerAn assembly of electrically-powered devices designed to ablate benign lesions of the skin through cooling (cryosurgery) and may in addition be intended for temporary reduction of pain, swelling, inflammation, and/or hematoma associated with minor surgical procedures. It includes a control unit, thermoelectric cooling unit and a noninvasive handpiece typically mounted on a mobile stand/trolley; it is not intended to use liquid refrigerant (cryogen).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(925)378-4400info@r2technologies.com

Regulatory Flags#

DUNS number
080023734
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019947632Dermal Cooling SystemM1-TIP3-20M1-TIP3-202023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756401678DeRoyalDEROYAL INDUSTRIES, INC.ILO2026-09-18
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILO2026-08-22
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31